A clinical trial to study the effects of mesalamine 800mg(Zydus,CHL) versus Asacol® 800mg (Procter & Gamble Pharmaceuticals) and placebo in patients with moderately active ulcerative colitis.
- Conditions
- Health Condition 1: null- Moderately active ulcerative colitisHealth Condition 2: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2010/091/000237
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
1. Subjects must provide the written informed consent prior to any study related activity/procedure being performed.
2. Subjects must be 18 years of age or older with no known medical conditions that, in the investigator?s opinion, may interfere with study participation.
3. Newly diagnosed or relapsing (relapsed ≤ 6 weeks prior to randomisation) active UC (score of 4?10 on a modified UC?DAI score). Diagnosis and scoring shall be based on the results of sigmoidoscopy/colonoscopy and biopsy, which shall be done within 2 weeks prior to randomization, and recall of symptoms of rectal bleeding and stool frequency of last 3 days before screening of the subjects.
4. Inflammation extending 15 cm beyond the anal verge confirmed by sigmoidoscopy or colonoscopy.
5. The sigmoidoscopy / colonoscopy score should be ≥ 1 for inclusion of subject. In case, on sigmoidoscopy, if the disease is not limited to 30 cm from anal verge and upper margin is not visible, then a colonoscopy shall be done.
6. Physician?s Global Assessment (PGA) score of 2.
7. Subject must understand and be able, willing and likely to fully comply with the study procedures and restrictions.
1. Subject is contraindicated to the use of 5-ASA or having known or suspected allergy to 5-ASA or salicylic acid (i.e. aspirin).
2. Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at a dose 2.4g/day for induction of remission within the previous year.
3. Previously failed to respond to steroids within the previous year.
4. Current relapse lasting more than 6 weeks prior to randomization.
5. Crohn?s disease, any active peptic ulcer disease, bleeding disorders, short bowel syndrome or history of bowel surgery in the past, except appendectomy.
6. Isolated proctitis, extent of inflammation being ≤ 15 cm from the anal verge.
7. In the opinion of investigator if subject has immediate or significant risk of toxic megacolon.
8. Impaired renal function (creatinine 1.2 mg %) or impaired hepatic function (AST/ALT 2 times UNL).
9. Subjects known to be HBsAg or Hepatitis C antibody positive.
10. Severe UC defined by the following criteria:6 bloody stools daily with one or more of the following:
a) Oral temperature 37.8°C
b) Pulse rate 90/min
c) Hemoglobin 10 g/dL
11. Stools showing positive culture for enteric pathogens (Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter) or those with Clostridium difficile toxin present or with ova or parasites as detected by microscopy.
12. The following treatment will be forbidden during the study (if present at selection, a wash-out will be necessary):
a) Loperamide and other antidiarrheal agents, mucilages, antibiotics: 1 week wash-out.
b) Oral or rectal steroids: 4 weeks wash-out.
c) Repeated treatment ( 3days of use) of non steroidal anti-inflammatory drugs (NSAID) oral or rectal route: 1 week wash-out (aspirin ≤ 325 mg/day used for cardioprotection is allowed).
d) Sulfasalazine 2.4g/day or mesalazine or 4-ASA at a higher dose than what is permitted in the local formulary or standard care for maintenance treatment: 4 weeks wash-out
e) Immunomodulating/suppressing drugs: 6 weeks wash out.
f) Probiotics: 1 Week
13. Pregnant, nursing mothers or any subject planning a pregnancy within the next 2 months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: sterilisation, Intrauterine device [IUD], oral contraceptives or double barrier methods).
14. Participation in another clinical trial or having taken an experimental drug within last 30 days prior to the study entry.
15. Previous participation in this trial.
16. Known or suspected abuse of illicit drugs and /or alcohol.
17. Unwilling or unable to comply with the protocol requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method